FDA Adverse Event
Malfunction
Summary report: N
KIT 11.5FX19.5 CE MAHURKAR
MDR report key: 2974526
·
Received January 28, 2013
Report
- Report Number
- 1317749-2013-00053
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Date of Event
- April 27, 2012
- Report Date
- January 11, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 01/28/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 01/13/2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER WAS IMPLANTED ON (B)(6) 2012. THE CATHETER WAS IN USE FOR 9 MONTHS. THE CATHETER BROKE ON THE VENOUS SIDE. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38420 | KIT 11.5FX19.5 CE MAHURKAR | DIALYSIS CATHETER | MSD | COVIDIEN | 8813793013 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |